Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

• Główni autorzy: Juan Almeida (Autor), Mariana Bezerra (Autor), Daniel Markl (Autor), Andreas Berghaus (Autor), Phil Borman (Autor), Walkiria Schlindwein (Autor)
• Format: Książka
• Wydane: MDPI AG, 2020-02-01T00:00:00Z.
• Hasła przedmiotowe: article
• Dostęp online: Connect to this object online.

A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established for the development of drug products/substanc...